Northeast Urologic Surgery Pc

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Northeast Urologic Surgery, PC laboratory on 08/07/2026 pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; and This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Director (LD) the laboratory failed to enroll in an approved proficiency testing (PT) program for all analytes. Findings include: 1. Review of the laboratory's PT Testing (NE.19.15) procedure states the laboratory "participates in a number of external proficiency testing programs" and "PT participation will mirror the scope and complexity of testing done by the laboratory." 2. Review of the 2024, 2025, and 2026 College of American Pathologists proficiency tests results revealed the laboratory did not enroll in PT for moderate complexity urinalysis on the Clinitek Advantage analyzer in FY 2025. 3. Interview with the LD on 8/7/2026 at 11:15 AM confirmed the above findings. 4. The laboratory performs 3700 urinalysis tests on the Clinitek Advantage annually. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to ensure proficiency testing (PT) samples were examined by personnel who routinely perform testing. Findings include: 1. Review of the laboratory's PT Testing (NE.19.15) procedure states "Supervisors must rotate testing personnel who engage in PT challenges such that no person is left out". 2. Review of the laboratory's CMS 209 form indicated 8 testing personnel (TP) performing urinalysis testing on the Clinitek Advantage analyzer. 3. Review of the College of American Pathologists PT records revealed 1 of 8 testing personnel (TP1) performed testing for 2024 CAP Event 3 urinalysis, 2026 CAP Event 1 urinalysis and 2026 CAP Event 2 urinalysis using the Clinitek Advantage Urinalysis analyzer. 4. The laboratory performs 3700 urinalysis tests using the Clinitek Advantage analyzer annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Northeast Urologic Surgery, PC laboratory on 09/12/2024 pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview the laboratory did not run external quality control (QC) in the subspecialites of Bacteriology each day of patient testing. Findings include: 1. Record review of Quality Control (QC) for the Quant Studio 3 Microbiology PCR analyzer revealed QC was run once a week, not every day of patient testing. 2. Staff interview on 09/12/2024 at 11:00AM: Testing personnel stated "we run QC on the Quant Studio 3 each week." Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --